EN 60601-2-37
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DIN EN 60601-2-37 |
|---|---|
| Area | Medical technology |
| title | Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic equipment for medical diagnosis and monitoring. |
| Latest edition | 5.2000 |
| ISO | IEC 60601-2-37: 1999 |
The EN 60601-2-37 with the title "Medical electrical devices - Part 2-37: Special provisions for the safety of ultrasonic devices for medical diagnosis and monitoring" is part of the EN 60601 series of standards .
The DIN standard DIN EN 60601-2-37 is published by the German Institute for Standardization .
The standard is based on the international version IEC 60601-2-37. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-37 , see DIN-VDE standards part 7 .
This supplementary standard regulates general specifications for the safety, tests and guidelines of ultrasound devices for medical diagnosis and monitoring. The purpose is to describe features of the basic safety as well as tests and to give additional instructions for their application.
validity
The German edition 5.2000 has been accepted as a German standard from the date of its publication .
- The current version (5.2000) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
- An A1 was published in 1.2004 and an A2 in 7.2005.
- Attention: The standard has been withdrawn, but may still be valid locally.
- A draft for use with the 3rd edition of DIN EN 60601-1 was published in 2008.
scope of application
(Abstract from Perinorm for the draft 12.2008)
The procedure and philosophy of this draft standard for diagnostic ultrasound devices are consistent with those of the current standards within the EN 60601-2 series, which apply to other diagnostic modalities such as: B. X-ray or magnetic resonance systems. In each of these cases, the intent is to require increasing refinement of the output power displays and / or control as the energy level of the diagnostic fields used for testing increases. Therefore, for all of these diagnostic modalities, it is the responsibility of the user to understand the risks to the output power of the systems and to act appropriately to obtain the desired diagnostic information with minimized risk to the patient.
extra information
The following changed requirements are contained in EN 60601-2-37 (extract):
- Protection from radiation
- Protection against excessive temperatures
- Protection against dangerous initial values